Job Description

The ideal candidate must have a degree level, preferably in a Science or similar field, and bring demonstrable experience from within the Pharma or Medical Device/ GMP / Regulated Industry. The candidate must be adept at assessing Quality Management System elements and their interdependence as well as a natural communicator, whether this is written or verbal, and be comfortable working in a fast-paced and dynamic environment.


Key responsibilities of the Quality Engineer (QMS):

  • Working with key stakeholders and within the QMS team, play a pivotal role in leading relevant departments in developing and implementing a Quality Management System based around ISO 13485, 21CFRPart4, and EUMDR.
  • Be the Subject Matter Expert regarding Acceptable Quality Standards for processes.
  • Support the company by helping review and approve necessary Procedures, Work Instructions, Forms and training.
  • To help develop a culture of continuous improvement within the Company.


Requirements

Experience:

  • A degree in a relevant engineering, design or science discipline (or equivalent qualification)
  • Appreciation for all stakeholders involved in new product development
  • 4 years’ experience in a highly regulated environment          
  • Developing and improving Quality Management Systems and the ability to interpret regulations
  • Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP
  • Experience auditing to ISO 9001 or ISO 13485 would be an advantage
  • Experience in product development and the application of Design Controls would be an advantage
  • Ability to lead and influence

APPLY NOW